Cleared Traditional

K882755 - MODEL 500V VASCULAR SPECTRUM ANALYZER

K882755 is an FDA 510(k) clearance for MODEL 500V VASCULAR SPECTRUM ANALYZER, manufactured by Multigon Industries, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K882755 · Multigon Industries, Inc. · Radiology device
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Nov 1988
Decision
147d
Days
Class 2
Risk

K882755 is an FDA 510(k) clearance for the MODEL 500V VASCULAR SPECTRUM ANALYZER. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Multigon Industries, Inc. (Mt. Vernon, US). The FDA issued a Cleared decision on November 29, 1988 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Multigon Industries, Inc. devices

FDA 510(k) Submission Details - K882755

510(k) Number K882755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1988
Decision Date November 29, 1988
Days to Decision 147 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 107d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 994
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K882755.
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